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510(k) Data Aggregation
(238 days)
Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.
Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.
Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.
Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.
The provided text does not contain detailed information about acceptance criteria for device performance or a study that specifically proves the device meets those criteria. The document is a 510(k) summary for an Air Compression Leg Massager, primarily focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results for the subject device.
The "Performance Data" section (VIII) lists several non-clinical tests performed to support the substantial equivalence determination, but these are primarily related to safety, electromagnetic compatibility, battery safety, and software validation, not the direct clinical performance of improving circulation or relieving aches and pains.
Therefore, many of the requested details cannot be extracted from this document. However, I can summarize what is present:
What is present in the document:
- Non-clinical tests performed: Biocompatibility, Electrical Safety and EMC, Battery Safety, and Software Verification and Validation.
- Result of these tests: They "passed" or "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels."
- Overall Conclusion: The device is considered "as safe, as effective, and performs as well as the primary predicate device and secondary predicate device" based on this analysis and non-clinical tests.
What is NOT present in the document (and thus cannot be filled in):
- A table of acceptance criteria and reported device performance for clinical effectiveness (e.g., specific metrics for pain relief or circulation increase).
- Sample size used for a performance test set.
- Data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
- Number of experts used or their qualifications for establishing ground truth (as no clinical performance study is detailed).
- Adjudication method for a test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
- Information on a standalone (algorithm only) performance study.
- The type of ground truth used for clinical performance.
- The sample size for the training set (as it's a physical device, not an AI/ML algorithm that requires a training set in the described sense).
- How the ground truth for the training set was established.
Based on the available information, here's a summary of the compliance for the listed non-clinical tests:
| Test Category | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance and Conclusion |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation) indicating the body-contacting materials (Nylon polyester for leg wraps, ABS, PC for enclosure) are safe for intended contact. This implies non-toxic, non-irritating, and non-sensitizing properties. | "The following testing was performed to, and passed, including: ISO 10993-5, ISO 10993-10, ISO 10993-23." This confirms the device meets the biocompatibility requirements. |
| Electrical Safety and EMC | Compliance with IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances - requirements and tests), and IEC 60601-1-11 (requirements for home healthcare environment). This implies the device safely operates electrically, does not interfere with other devices, and is safe for home use. | "Electrical safety and EMC testing was performed to, and passed, the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11." This confirms compliance with international safety and EMC standards. |
| Battery Safety | Compliance with IEC 62133-2 (safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems). This implies the internal lithium battery meets safety standards to prevent hazards like overheating, fire, or explosion. | The testing for IEC 62133-2 was performed and passed, implying the battery components are safe. |
| Software Verification and Validation | Basic documentation consistent with 510(k) requirements. System validation testing to demonstrate that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. This implies the software (firmware/microprocessor control) functions as intended and is free from critical defects that could pose a safety risk. | "Software documentation consistent with basic documentation this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This confirms the software's functional and safety integrity as per the established requirements. |
Study that proves the device meets the acceptance criteria:
The document states that the substantial equivalence determination is supported by these non-clinical performance data. It does not describe a clinical study measuring the device's efficacy in achieving "temporary relief of minor muscle aches and pains" or "temporary increase in circulation," as the FDA often relies on technological similarity to a predicate device for this type of claim, assuming the predicate's effectiveness. The listed tests are primarily aimed at ensuring the device's safety and fundamental operational integrity as an inflatable tube massager.
Therefore, for the clinical performance claims (pain relief, circulation increase), the "study" is implicitly the demonstration of substantial equivalence to already cleared predicate devices that have established these claims, rather than a de novo clinical trial with specific clinical acceptance criteria for the subject device.
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